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OpenTrials
Completed

NCT Number: NCT05171764

Dual Energy Cardiac CT Data Collection and Evaluation

This study is intended to collect clinical feasibility data using this prototype research mode for the purposes of understanding potential clinical impact, potential limitations and strengths, and to further develop the technique through development of image reconstruction and processing approaches or identification of other areas of development required.

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Key information

Conditions

Cardiovascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zürich University Hospital

Zurich, Switzerland

About this study

Up to 38 subjects may be enrolled to achieve the target number of 30 evaluable subjects. Withdrawn or discontinued subjects who are enrolled and received the investigational scan, may be replaced. Subject participation will be deemed complete once the diagnostic and investigational scans are completed. A subject is considered evaluable when images and raw data from the diagnostic single energy cardiac CT scan and raw data from the investigational dual energy cardiac CT scan have been collected successfully and demonstrate a diagnostic interpretation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients > 50 years old undergoing routine cardiac CT imaging exam;
  • Patients that within last 12 months did not undergo medical procedures involving ionizing radiation;
  • Signed informed consent.

Exclusion criteria

  • Contradictions to contrast;
  • Contraindications for beta blocker;
  • BMI >30;
  • High heart rate ≥75 BPM;
  • Atrial Fibrillation;
  • Arrythmia or irregular heartbeats;
  • Pregnant women;
  • Patients lacking capacity in providing informed consent
  • Patients who did participate in prior research studies with ionizing radiation in the last 12 months.

Treatment and study plan

Additional Gemstone Spectral Imaging (GSI) cardiac scan

Device

After the subject undergoes the clinically prescribed cardiac Computed Tomography (CT) scan for their diagnostic purposes, the investigational Gemstone Spectral Imaging (GSI) scan will be conducted following the diagnostic CT scan utilizing the same contrast administration.

Primary outcomes

  1. Collect Data

    Time frame: through study completion, an average of 1 year

    Data will be collected from the scanner for future post-processing and engineering development. There is no analysis planned at this time for the data, simply data collection.

Secondary outcomes

  1. Evaluation- Likert Scale

    Time frame: through study completion, an average of 1 year

    Complete an image evaluation using a 5 point Likert Scale (1 - Non-Diagnostic to 5 - Excellent Image Quality), done by a qualified cardiac imaging expert.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • University Hospital, Zürich

Registry information

Official study title

Feasibility and Data Collection of Dual Energy Cardiac CT on a Wide Coverage System

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 29, 2021
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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